Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465537
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
CRISPRCas9 Instantaneous Gene Editing Therapy to Intraocular Hypertensive POAG With MYOC Mutation
Sponsor:
Shanghai BDgene Co Ltd
Organization:
Shanghai BDgene Co Ltd
Study Overview
Official Title:
A Clinical Study on CRISPRCas9 Instantaneous Gene Editing Therapy to Primary Open-angle Glaucoma With Elevated Intraocular Pressure and MYOC Gene Mutation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intented to evaluate the safety tolerability and preliminary efficacy of CRISPRCas9 Instantaneous Gene Editing Therapy BD113 virus-like particle also BD113vLVP in patients with primary open-angle glaucoma POAG with elevated intraocular pressure and MYOC gene mutation The main objectives to evaluate the safety and tolerability BD113vLVP in POAG patients with intraocular hypertension and MYOC mutation and secondary objectives is to explore the preliminary efficacy and the metabolism characteristics of BD113vLVP in participants
Detailed Description:
This is an open single-dose two-arm non-randomised clinical study A total of 6 to 9 POAG patients with high intraocular pressure were enrolled and divided into two test groups Test Group 1 recruits 3 POAG patients who have elevated IOP and positive or negative MYOC mutation and target interventing eye is no vision Test Group 2 will recruit 3 to 6 POAG patients with MYOC mutations and visual acuity In order to better verify the lowering IOP effectiveness of BD113vVLP another 2 or 3 participants will be recruied in Group 2 on-demand Each participant will receive single dosing BD113vVLP 4µg p24 by intracameral injection in the interventing eye then conduct the evaluations of the safety and efficacy according to visit schedule in 1 year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None